IPBiz

Intellectual property news affecting business and everyday life

Saturday, March 31, 2007

Armando Cordova

The story of chemist Armando Cordova is making the rounds. It's not about plagiarism, but it is about one person taking information from a second person and using it to the advantage of the first person.

It is relevant to the patent reform debate. Patents, at the basic level, offer legal protection in return for disclosure. That is, if an "information discloser" provides information to the USPTO conforming to the requirements of patent law, the "information discloser" gets some legal protection. The "information discloser" is free to talk about his invention publicly, to make deals without fear that someone will steal his idea.

A more complicated instance involves a clever scientist named Donna Blackmond, who published research which extends well outside of my field in an area which, I get the feeling, she pioneered. She gave a lecture in Stockholm on findings she had recently submitted to Nature. Armando was in the audience, took notes and quickly unleashed his lab to perform a slew of sloppy experiments, haphazardly analyze the data and submit the stolen conclusion to a journal with a more rapid review process: Chemistry - A European Journal. He did not cite her work. Blackmond rightfully complained, an ethics review was commissioned and having found Armando violated ethical guidelines, he was forced to write a retraction in Chem. Eur. J. As it turns out, the article and the retraction were published in the same print journal. Armando’s evil doesn’t end there though. As he was in the process of being investigated for ethics violations and forced to write a retraction, he submitted a similar paper to Tet Let. A paper with a review process faster than a fart. You have to imagine the magnitude of this. He’s so unethical, that not even a commission devoted to forcing him to apologize detoured him from publishing the same shit he stole AGAIN.

IPBiz notes that in the law review business there are additional pathologies. If one can find something written down, one can refer to it and cite it, even if it's wrong. Thus, there have been a number of citations to the 90%+ "patent grant rate" of Quillen and Webster, even after the original authors modified there viewpoint in print. Thus, eBay used the false grant rate in a brief to the Supreme Court in 2006, years after the number had been modified. In 2005, within the Stanford Law Review, Lemley referred to Gary Boone as the inventor of the integrated circuit, and did not mention Noyce or Kilby. Lemley had earlier asserted that the inventors of the transistor foresaw uses only for hearing aids, based on a published interview with a professor at Stanford (who was not in the sciences).

“Science depends on openness: we expose our scientific findings, including the details of how they were obtained, to the scrutiny of the scientific community. This sounds like a prescription for chaos, but the result is the opposite because it reinforces the idea that science is conditional – always subject to being replaced by better information. This can be frustrating to non-scientists, who ask why science can’t make up its mind, but the alternative is dogma. Openness provides a mechanism for self-correction, setting science apart from other ways of knowing. Science is, in fact, the only way of knowing. Anything else is just religion, which is all about authority.

“So, science rejects authority. Anyone can play, including ‘outsiders.’ Perhaps the most fundamental of all natural laws, that of the conservation of energy, was first recognized in 1842, not by a physicist but by a doctor studying human metabolism. This law might yet be disproved, but of the half-dozen attempts to challenge it every year, some are merely foolish, most are fraudulent, and all have been wrong.”

Shankar Vedantam of the Washington Post wrote: Under the [proposed] new rules, any scientist or physician who has had $50,000 or more in financial ties to a company over the past 12 months, including stock or consulting arrangements, would be barred from panels [of the FDA] evaluating that company's products. Those who have received less than $50,000 in the previous year might be allowed to participate in the discussion but could not vote.

Randall Lutter, the FDA's acting deputy commissioner for policy, was quoted: "We are very interested in ensuring we have the best possible access to scientific experts. At the same time, we seek to ensure we have the fullest public confidence in the integrity of our advisory committee process."

Curiously, although Lutter's comment is directed to the problem of an expert favorably reviewing the expert's own products, the comment could equally well be applied to peer to patent, wherein an expert at company A might UNFAVORABLY review the patents of his competitor, company B.

An AP article posted on redmondmag titled "Infringement Fears Haunt IBM" is so filled with errors it is hard to discuss.

The gist of the central theme is that participating companies may incur liability for willful infringement because they have read applications. The whole point of the patent system is that interested parties, including competitors, ARE SUPPOSED TO READ issued patents (and probably published applications). Infringement damages per se and injunctions may be awarded whether or not one has read the issued patent. The whole premise of the article misunderstands what patents are about. The gain to the public is PUBLIC DISCLOSURE of information.

The article states: Yet some engineers, attorneys and others worry whether comments on a rival's application could make them vulnerable later to willful or deliberate infringement charges. The article seems to say that "comments" could create willful infringement liability. Not clear what the article means by that.

The article also states: The goal is to provide government examiners with the most current and informed opinions of professional, academic and everyday experts, Noveck said earlier this week at a forum to discuss the project.

The article also states: IBM, which has been the leading U.S. patent recipient every year for more than a decade, endorses legislation that would require a patent holder to first notify a company or individual of a willful infringement allegation before filing a lawsuit. The hope is to reduce lengthy, expensive trials that in many cases could be handled out of court.

The article misuses the word "innovation": At least part of the delay is that competition drives companies to start with broad patent claims and then refine them to a specific innovation after repeated denials from patent examiners.

It's not clear what the article means in the following: Critics of the program though are concerned about the potential of "inequitable conduct" court findings that can invalidate [sic] patents when companies fail to submit all relevant information needed to assess whether an application is patent-worthy.

The letter of Congressman Brad Miller to the President of Purdue University gave Purdue until 5pm on Friday, March 30, 2007 to turn over the report on the investigation into Taleyarkhan's work on bubble fusion. What happened? Reports attributed to AP are all over the map.

Purdue spokeswoman Jeanne Norberg said Friday [March 30] that the university intends to provide all of the information requested by Miller's committee, which originally set a deadline of Friday but extended that until April 5 at Purdue's request.

There are some issues with the Callahan story. Callahan noted:

That statement, and the fact that taxpayer money - including about $800,000 from the Department of Defense - has been spent trying to independently recreate Taleyarkhan's findings caught the attention of the House Committee of Science and Technology. IPBiz notes that if an earlier IPBiz commenter is correct, the $800K went to UCLA/Putterman, largely for a capital equipment purchase. Presumably, the capital equipment is still there and available for other uses. IPBiz separately notes that money spent to independently re-create findings was an issue in the frauds of Jan-Hendrik Schon and Hwang Woo-Suk. The waste in resources imposed by such exercises is clear evidence that the "rational ignorance" approach of Mark Lemley should be repudiated.

Of the issue raised by Purdue of confidentiality, the Callahan story states:

Norberg said the university cannot comment on the nature of those allegation because a university policy prevents the release of information about misconduct investigations because those could damage the reputations of researchers, including those making the charges.

"That policy was established not only to give us an outline for how to do a review but to do it in such a way that it did not harm someone's reputation in the process," she said.

IPBiz notes that in the Baltimore/Imanishi-Kari matter, a lot of people changed their minds, and Baltimore got an apology of sorts from the New York Times. (see discussion in 88 JPTOS 239) IPBiz notes that Purdue officials have sent letters to the New York Times and Nature, apparently criticizing THEM for not fully explaining the confidentiality policy. [See text at the end of this post.]

Callahan noted there were criticisms of Taleyarkhan's work:

At the same time that Science paper appeared, however, two Oak Ridge researchers took the unusual step of publishing dissenting research saying that Taleyarkhan's work was inaccurate.

IPBiz notes that the more unusual aspect is that the journal agreed to publish work criticizing something appearing in Science. See 88 JPTOS 743 for a case in which Science dug in its heels and stood by a false story.

Callahan talked about the article in Nature in March 2006:

In March 2006, two Purdue researchers claimed in an article in the British journal Nature that Taleyarkhan had attempted to thwart their efforts to test his "bubble fusion" claims. They also said their confidence in his work has been seriously shaken.

IPBiz notes that one without background in this story might think two Purdue researchers AUTHORED an article in Nature. The March 2006 article was authored by Eugenie Reich, a free lance journalist. Reich had also authored an article published in Nature in this time period suggesting Baltimore might be guilty of more fraud.

Callahan had a quote from Ken Suslick on March 30, 2007:

Suslick said he wrote to Purdue last June, before the first inquiry was completed, raising those and other concerns. He said Purdue officials never contacted him about that letter.

"The Purdue administration has been as nontransparent and as obscure about what their investigation concerned as they could possibly be," Suslick said Friday [March 30].

The committee has given Purdue until April 5th to turn over copies of the panel's findings. (...) Purdue spokeswoman Jeanne Norberg says the university intends to provide all of the information requested by the committee.

A congressional subcommittee has given Purdue until Thursday [March 29] to turn over copies of its findings into the allegations raised last year against Rusi Taleyarkhan, a professor of nuclear engineering.

Provost Sally Mason and Charles Rutledge, Purdue's vice president for research, sent letters to The New York Times and Nature after both publications published articles about the university's unwillingness to discuss the investigation.

"The author of the article apparently is unaware of the fact that the Department of Health and Human Services' integrity guidelines require American institutions to protect 'the confidentiality of respondents, complainants and research subjects' when investigating allegations of misconduct," the letter to the Times said.

The fate of the letters is unknown:

Mason and Rutledge in their letters stood behind the policy and claim articles in Nature and the Times were unfair because it did not clearly outline the university's policy.

Employees at the Times and Nature said they could not find the letters in their archives and do not believe they have published them.

Friday, March 30, 2007

Further to the Ohio University plagiarism scandal, one student apparently has been stripped of his degree. THE COLUMBUS DISPATCH reported on March 29, 2007:

Ohio University revoked the master's degree of a student who had extensively copied material and had been deceptive in writing his thesis, school officials said yesterday. (...) Dennis Irwin, dean of OU's Russ College of Engineering and Technology, said the person whose degree was revoked was not given the option of rewriting his thesis. He appealed the recommendation of the university's Academic Honesty Hearing Committee to revoke his degree, but his appeal was turned down, Irwin said.

Patents were a topic at a hearing of the House Small Business Committee (Nydia M. Velasquez, D-N.Y, chair) on March 29, 2007, discussed by BusinessWeek.

Rep. Charles Gonzalez, D-Texas, said he sympathized with major technology and pharmaceutical firms that claim to be barraged with sometimes frivolous lawsuits, but noted that they would always have more resources than small businesses to defend and protect patents. IPBiz notes it's usually IT companies complaining about patent trolls.

Of peer-to-patent, IBM Corp., Microsoft Corp., General Electric Co., Hewlett-Packard Co., Oracle Corp. and Red Hat Inc. have funded and agreed to community review of 250 software patent applications. Small businesses and individual inventors also are participating, but some have expressed concerns that they'll be picked apart by the larger firms, USPTO Commissioner John Doll said.

"We think in fact our patent system is the gold standard in the world," said Brian Lord, general counsel for New Hampshire-based AmberWave Systems, which researches, develops, patents and licenses advanced semiconductor materials technology. The firm, which has 23 employees, recently reached a licensing deal with Intel related to AmberWave patents for strained silicon used in chips.

BusinessWeek had earlier presented opinions by Kappos of IBM. Innovation and Its Discontents co-auther Jaffe had testified before Congress in Feb. 07:

Thursday, March 29, 2007

Stem cells and electric cars

I. Stem cells

One commenter wrote: One must also consider that if one suggests the use of adult stem cells they currently are not ready to grow into any type of cell. Yes there have been reports that Verfaille has shown how to do that, but have you heard her work is now under investigation, similiar to the duplicate photos of Hwang.

The commenter also wrote: I see a small hard core group of people pointing out we don't need to study hESC because adult stem are the only cells we need to cure all disease.

IPBiz responds: Show some evidence that anyone has a program for TREATMENT of HUMANS using embryonic stem cells that has a reasonable chance of utilization on a ten year time scale. One gets the idea that the taxpayers who are funding Proposition 71 think they are getting TREATMENTS and CURES, not research tools for someone else to create treatments and cures. The Cha proposal, funded by CIRM, is for a research tool, not for a treatment.

Aldhous said he was intrigued with Verfaillie's 2002 study published in Nature, because “it was a remarkable and exciting finding.”

He said he wondered why no one else had been able to duplicate her results.

IPBiz wonders why NO ONE ELSE has been able to do what Hwang claimed to have done EITHER in 2004 OR in 2005. It's all well and good to create research tools based on the use of embryonic stem cells. The Cha proposal would do something useful, but it's hardly step-out work. All the technology to do that is in place now, and it's just a matter of doing it. But if one can't do what Hwang claimed, one is not talking about innovative TREATMENTS of HUMANS.

Meanwhile, what Timothy Johnson reported is about TREATMENT of HUMANS. Real humans were treated for a real cardiac problem with real (adult) stem cells in a Phase I study. Immune rejection problems were addressed. This real treatment has a reasonable chance of utilization (FDA approval) on a ten year time scale.

This isn't about needing (or not needing) to study embryonic stem cells. It's about telling the truth about what treatments are realistically obtainable on a ten year time scale. This isn't about whether or not the Cha study will obtain useful information. It's about telling the taxpayers that their money is being spent on a "research tool," not a treatment. It's also about telling the taxpayers who is going to benefit from the use of research tool, including whether or not the researchers have an economic interest in the outcome of the research.

One of the more remarkable, and least discussed, aspects of the Hwang fraud is that the the article submitter did check a box indicating there were economic interests of the authors in the research results submitted (e.g., patent application) and Science did not bother to check this out further.

II. Electric cars

Electric vehicles enjoyed success into the 1920s with production peaking in 1912. [See The History of Electric Vehicles.] That's one year after Henry Ford won his suit against the folks who controlled the Selden patent, who coincidentally were the electric car people. Hmmmm. The electric car people, unlike Henry Ford, were not working to drive down production costs. They controlled the Selden patent. The price of the less efficiently produced electric vehicles continued to rise. In 1912, an electric roadster sold for $1,750, while a gasoline car sold for $650. The discovery of Texas crude oil (Spindletop) reduced the price of gasoline so that it was affordable to the average consumer.

Things now are a little different. There are no more Texas oil fields to discover, so the future of a high-energy density liquid fuel may be questioned. There are other energy sources, coal and nuclear, to make electricity.

Of the text --Perhaps if you re-look at the electric motor you will realize it really wasn't suited for the long haul until recently and still cannot replace the internal combustion engine. So why are you trying to suggest we shouldn't have gone through the natural process of using the internal combustion engine until technology has made the electric motor a serious contender,-- it is NOT the electric motor that wasn't suited for the long haul, it was the batteries. Surprisingly, not that much has changed in battery technology for vehicles between 1912 and now.

Of course, the technology that "worked" to put commercial electric vehicles on the road ca. 1912 is still around. That's just like the technology for repeating Spencer rifles was around in 1876, when Custer and his men were using single-shot rifles against Crazy Horse and friends, who were armed with repeating rifles. The concept of "innovation" can be very pliable. For electric vehicles, it is not the electric motor that is at issue, it's the battery and it's the cost of fuel. And the latter is changing. Battery-fueled vehicles may not compete with gas cars on energy density, but they may compete on energy density per dollar.

DaimlerChrysler AG promised a production fuel-cell vehicle by 2004, but couldn't deliver despite spending $1 billion on the technology. And little came of a $1.5 billion taxpayer-funded effort, called the Partnership for a New Generation of Vehicles, to build an 80-miles-per-gallon car. Last year, Ford Motor Co. took an image beating when it backed away from a pledge to put 250,000 hybrids on the road by 2010.

Of the Volt itself:

The Volt grabbed headlines, lit up online chat boards and dominated the buzz at the auto show in Detroit.

There's just one problem: The Volt may never get built.

Production depends on advances in battery technology that could be years away. The uncertainty led to intense debate within GM over whether it was wise to show the Volt in Detroit. And now that the world's waiting for GM to deliver what could be the biggest environmental breakthrough so far this century, company officials are actively trying to temper expectations.

***Separately, californiastemcellreport has some discussion about selling eggs.

Deja vu, all over again: patent abuse and research misconduct

﻿The beginning of the decision reads: "The subject is most important; the interests involved, of great magnitude; the record phenomenally long; and the questions presented, complex." The decision continued: "During this long time the [...] art made marked advances along different lines, and when, in [...], the patent was granted, it disclosed nothing new. Others had then made the patentee’’s discoveryand had reduced it to practice in ignorance of what he had done. While he withheld his patent, the public learned from independent inventors all that it could teach. For the monopoly granted by his patent he had nothing to offer in return. The public gained absolutely nothing from his invention, whatever it was.From the point of view of public interest it were even better that the patent had never been granted."

The patent in question is not to a business method, nor even to such a thing as BT's claim to a hyperlink. It is not a patent to Lemelson. The patent in question is US 549,160 issued in 1895 to a Rochester lawyer named George B. Selden and the decision in question is Columbia Motor Car Co. v. C. A. Duerr, 184 F. 893 (CA 2 1911), which found, among other things, that Henry Ford's cars did not fall within the scope of the patent, mainly because Ford's cars employed an engine different from thatdisclosed in the '160 patent.

This 2001 text suggests that the central conjecture of Jaffe and Lerner writing in the year 2004, that patent problems have arisen in the last 20 or so years, is subject to criticism.

****

Separately, as an update on Brad Miller, Purdue, and bubble fusion, wibc reports:

But Congressman Brad Miller says Purdue is changing its response to his request for documents pertaining to the research, and the use of federal grant money for that research.

Miller says initially, Purdue stated it would cooperate fully with the request. But he says now is communicating through its lawyers.

Purdue has issued a statement saying it intends to comply with the congressional committee's request. But officials say they need to go through lawyers because of certain legal obligations under university policy.

IPBiz still says Miller will get the report, but it will be designated confidential.

***The Purdue business involves DARPA funding. To get ahead of the curve for those of you who might be wondering-->

NSF is an Independent Agency, its appropriation comes under the Appropriations Subcommittee on Science, the Departments of State, Justice and Commerce, and Related Agencies. NSF has an Office of the IG. Congress has oversight though NSF's IG, who submits reports to Congress each year.

***For those interested, the Office of Research Integrity (ORI, of HHS) publishes a newsletter. The March 2007 newsletter notes that in 2006 there were the highest number of misconduct findings and closed cases since 1996. One debarred respondent had been at two institutions, and there was a separate case number for each.

Those who suggest the Hwang fraud was "one bad apple" should take note.

Blacklight tried to get some researcher friends of mine at Princeton to do some experiments for them to boost Blacklight's credibility. Gave them a free 1,000-page tome called "The Grand Unified Theory of Quantum Mechanics" as part of the buttering up - one of them who read through it and told me it was filled with bad physics. Needless to say, they did not collaborate.

Drakvil, notallwhowander and bug: Most hydrogen atoms on Earth (99.985%) have one proton and one electron. If you want to give it a name, it's usually called protium, as opposed to deuterium (1 proton, 1 neutron) or tritium (1 proton, 2 neutrons). If you could create a stable electron-proton system with lower energy, statistical mechanics (the math behind thermodynamics) says that would be the preferred state, and most hydrogen would already be there. My best guess is he must be talking about doing nuclear physics and reversing a beta-decay. If he can do it, more power to him, as long as he doesn't take any money out of my pocket for his research.

IPBiz notes that someone could say the same about those who promise TREATMENTS from embryonic stem cell research within 10 years: If you can do it, more power to you, as long as you don't take any money out of my pocket for your research. If, however, all you are really doing is creating a "research tool," be clear about that, and let's discuss it. Tricking people about the likelihood of treatments is unacceptable.

Battery-powered vehicles, in 1899 and now

Sure there were electric motors way back and also in autos, but they didn't replace the horse, or even the internal combustion engine, because they weren't practical till only recently when battery technology permitted a longer range of travel.

In the article ﻿"Looking Backward," which appeared in IPT in June 2001 (and is available through LEXIS), LBE had written

﻿First, one has to understand the state of technology at Selden's time. In 1899, four years after the Selden patent, 1575 electric vehicles, 1681 steam cars and 936 gasoline cars were sold. [3] Based on the similarity of components such as motors, controllers, switches, and batteries, the electric vehicle companies planned a vertical integration including cars and streetcars. Furthermore, the electric carlooked technically promising. ““La Jamais Contente”” became the first car to reach 100 km/h and the ““Lead Wedge”” was the first car to reach 100 miles per hour. And, Thomas Edison was going to solve the ““battery problem.””

Using the criterion of "success in the marketplace" favored by many business professors, electric cars were "practical" in 1899. They were outselling gasoline cars in the marketplace. Further, until the invention of the starter for gasoline cars, electric cars were the vehicle of choice for women. Electric cars were practical and were selling in the marketplace.

There is a highly relevant point of history. From the 2001 article of LBE:

﻿In 1903, the Electric Vehicle Company joined forces with Packard and Oldsmobile to form the Association of Licensed Automotive Manufacturers (ALAM), which served as a conduit for licensing fees of ca. 1 1/4 percent on annual sales, based upon the Selden patent. Arguably, ALAM was conceived as a more pernicious entity than anything we have in the year 2001.

Henry Ford tried to join in 1903, but was rebuffed. In one version of the story, his 1903 application was denied on the basis his company was more an ‘‘assembler of parts’’ than a true ‘‘manufacturer’’. Although somewhat debated, the real issue was price fixing of the cars, rather than the technology per se. Unlike today’’s rather tame times, there was a real issue of lawsuits against buyers. ALAM ran ads““Do Not Buy a Lawsuit with Your Automobile”” and Ford, in turn, took out ads took offering to indemnify both buyers and sellers of his cars from any lawsuits claiming Selden patent infringement.

Think about this for a moment. "The Electric Vehicle Company" had the patent purporting to control gasoline-powered cars.

Endnote 4 of the 2001 article is highly relevant to recent discussions about Edison, the light bulb, and J.P. Morgan (and served as the basis for the title of the 2001 article):

﻿To the extent that Selden’’s idea was not to build such a vehicle but to wait around for someone else to do so and then cash in on his patent, there is relation to Edward Bellamy’’s ““Looking Backward”” (1888), which was published between the application (1879) and issuance (1895) of Selden’’s patent:

““Living in luxury, and occupied only with the pursuit of pleasures and refinements of life, I derived the means of support from the labor of others, rendering no sort of service in return.”” ““In the United States there was not, after the beginning of the last quarter of the century, any opportunity whatever for individual enterprise in any important field of industry, unless backed by great capital.””

IPBiz notes that Edison secured backing from J.P. Morgan and the Vanderbilts, and formed Edison Electric, ALL BEFORE he applied for his basic patent on the light bulb, which issued in 1880.

The Ni-Cd battery technology used in SOME vehicles today existed at the time of Edison. These batteries STILL are not practical for long range driving in a car powered ONLY by batteries. The batteries, then and now, were suitable for short range driving.

The commenter of March 28 raised a different point:

So be it with stem cells, when and if adult stem cells can act like hESC we could utilize them instead of hESC, until then it would be rather harmful to hold back research with hESC that could relieve suffering and premature death from disease.

The "claim to fame" of hESC will be attained when SCNT (or something like SCNT) can be used to make stem cell lines CUSTOMIZED to a given patient to avoid immune rejection problems. Hwang Woo Suk claimed to have done this. In the more than one year since the Hwang fraud was generally recognized, NO ONE HAS DONE WHAT Hwang claimed to have done in either the first or the second Science paper. That is a big problem for the "claim to fame." The criticized Cha proposal only proposed a genetic screening tool, not a treatment to relieve suffering.

***Further

Not only is Cha's genetic screening tool not a treatment, it is apparently based on the use of SCNT:

On March 16th, 2007, CHA RMI was awarded a $2,556,066 grant from theCalifornia Institute for Regenerative Medicine (CIRM) to conductresearch in the "Establishment Of Stem Cell Lines From Somatic CellNuclear Transfer-Embryos in Humans."

Thus, to get their tool, Cha will have to perfect SCNT in humans, the technique falsely claimed by Hwang Woo-Suk, and, to date, unattained in any lab in the world.

Patent Reform: Jaffe/Lerner and Kappos

An earlier IPBiz post questioned certain statements made by IBM's David Kappos, and focussed on one issue of how effective third parties will be in evaluating potentially invalidating prior art. One point in the IPBiz post pertained to the Jaffe/Lerner anecdote about how the USPTO missed a key reference in allowing US 6,049,811 over (alleged) prior art in a patent journal, 74 JPTOS 315.

IPBiz pointed out that nothing in 74 JPTOS 315 invalidated the claims of US '811.

IPBiz notes that an earlier book review of Innovation and Its Discontents had questioned Jaffe/Lerner about the US '811 story.

The book review in question is by J. Steven Rutt and appears in 2 Nanotechnology L. & Bus. 111 (2005). It is not entirely favorable to Innovation and Its Discontents:

Although Innovation is a good read, unfortunately, the title is incorrectly alarmist: with all due respect, the patent system is not broken. Certainly, our patent system, like democratic government itself, is dynamic, is in need of improvement and is becoming more complex every year. But it is not broken.

Rutt gets into the issue of the '811 patent:

One example is noted for why patent lawyers are needed to address these important policy issues surrounding the PTO. In providing anecdotal evidence, Innovation considers U.S. Patent No. 6,049,811 (issued Apr. 11, 2000), which is --ironically --directed to a "Machine for Drafting a Patent Application and Process for Doing So." Innovation describes prior art from Hitachi which was not cited by the Patent Office in granting the patent but allegedly destroys the novelty of this patent. In other words, Innovation uses this patent's story to support the broader notion that the PTO too often carelessly grants a patent which should not have been granted. This writer, however, observes that the '811 patent claims specifically require that:the claims are drafted before the summary of the invention, abstract, and the detailed description of a preferred embodiment of the invention is drafted; and the computer requires drafting the sections in a predetermined order prohibiting jumping ahead to draft a latter section. [footnote 7]

The Innovation authors, however, utterly fail to discuss the seminal point of whether the Hitachi prior art teaches this required feature of the invention. Hence, on first glance, even without studying the '811 patent and the Hitachi prior art more carefully, one skilled in patent law would find it is not so unreasonable that the '811 patent claims issued as a patent are novel over the prior art. It is quite possible, in fact, that the Hitachi prior art led the skilled artisans away from this feature of the '811 patent claims and, contrary to the authors' suggestion, actually supported the notion that the '811 patent claims deserved to issue. Moreover, the Innovation authors fundamentally miss the important point that it is quite possible that the Hitachi prior art is merely cumulative to the prior art which was cited, including the background discussion in the '811 patent, which is fairly extensive. In other words, the Innovation authors attempt to characterize the '811 patent as an embarrassing example of PTO carelessness, but even a brief look at the issue by a trained patent attorney confirms that it is not so embarrassing after all. The general scenario is frequently encountered that nanotechnology inventors and patent managers, including (p. 114) highly intelligent and highly technically trained people with advanced degrees, believe that some set of prior art somehow "knocks out" a patent claim. Upon inspection of the details, however, the patent claim may in fact legitimately be patentable.

Thus, Rutt clearly raised the issue that Jaffe/Lerner never showed 74 JPTOS 315 was prior art: [JL] utterly fail to discuss the seminal point of whether the Hitachi prior art teaches this required feature of the invention.

However, Rutt himself did not reach the seminal point (and does not cite 74 JPTOS 315 in his footnotes). In the earlier IPBiz post, IPBiz did reach the seminal point and concluded that 74 JPTOS 315 DID NOT TEACH what is claimed in the '811 patent. The USPTO did NOT miss a relevant reference. The teaching of 74 JPTOS 315 is not even cumulative.

Rutt does make a point relevant to the likely success of peer-to-patent and and Kappos' arbitrage: highly intelligent and highly technically trained people with advanced degrees, believe that some set of prior art somehow "knocks out" a patent claim. Upon inspection of the details, however, the patent claim may in fact legitimately be patentable.

IPBiz further notes: at the end of the day, there has to be someone at the USPTO who has the skills and training necessary to evaluate all the assembled prior art and make the right decision. The glaring evidence that Jaffe and Lerner "got it wrong" about 74 JPTOS 315 shows how difficult this task can be. When one chooses "argument by anecdote" and gets the anecdote wrong, there is problem. There is not a lot of evidence in Innovation and Its Discontents to back up the contention.

Rutt's conclusion stated: Nanotechnology's time has come, many believe. The patent system will not stop that. Innovation, despite its merits, unfortunately is excessively alarmist. The authors apparently seek to compare the present patent system to a mythical, past patent system which supposedly operated better; but, unfortunately, such a better system is indeed mythical. Based on this writer's experience in the daily trenches of nanotechnology and the patent system, (i) use of the system by money-conscious, competitive nanotechnology companies appears to be increasing, which reasonably suggests there is good value in the system; (ii) new nanotechnology product concepts appear to abound, which suggests the system forms a good basis for useful technology transfer and product development; and (iii) foreign governments look to the U.S. and its system for leadership in developing innovation systems which rely on patents. These are not signs of a broken system. The January 24, 2005 cover of Red Herring states that nanotech investment is "bruised but not dead;" by analogy, the U.S. patent system arguably may be bruised but is very much alive, evolving and supporting nanotechnology companies and their investors.

IPBiz notes, at the time of publication, Rutt was listed as an associate in the Intellectual Property Department of Foley & Lardner (he would not seem to be an intellectual property professor). IPBiz has not found an article by an intellectual property professor which addressed the defects in the JL argument about 74 JPTOS 315.

****Note that there are patent attorneys who OPPOSE post-grant opposition. See for example Joseph Hosteny such as "Post-Grant Opposition: Building on Sand," Intellectual Property Today [IPT], pp. 8-9 (August 2004) or What Now? Post-Grant Oppositions and the Proposed Budget, IPT pp. 8-9 (March 2005). [as mentioned in "Getting the Patent Reform Wars on Track" at http://www.ipfrontline.com/depts/article.asp?id=14520&deptid=4]

Some of the debate about post-grant opposition concerns timing. For some proposals, see

Wednesday, March 28, 2007

More on the Wright Brothers and stem cells

There was a comment to my March 25 post on an ABC News report of a promising treatment for cardiac injuries involving ADULT stem cells:

You may be on to something! You are right, if we don't do any hesc research we won't make any advances with it. The opposition is not only the well oiled pro-life lobby, but maybe adult stem cell researchers worried if advances come from hesc, they might find it hard to compete for grants. Pointing out that adult stem cells can work for a specific condition does not mean it can cure all conditions and we should not take that to mean hesc is not necessary. If we never studied internal combustion you would still be travelling on a horse. Who knows, given the same mentality, we might still be under the assumption the earth is flat.

IPBiz found the justaxposition of "compete for grants" and "internal combustion engine" interesting. Back at the time of the internal combustion engine, people were not competing for grants in order to make inventions.

The dark forces now seem to include "the well oiled pro-life lobby" [which did not do a particularly good job on Proposition 71, managing to get out-spent by a considerable margin] and "adult stem cell researchers" competing for grants against the "embryonic stem cell researchers." Getting back to the March 25 post, IPBiz was talking about an accomplishment that might be useful to patients. Remember them?

[In passing, IPBiz notes that a DIFFERENT IPBiz commenter suggests that "grant issues" may be motivating some of the concerns about Purdue's bubble fusion. IPBiz notes "grant issues" were a plot line on a Law & Order episode back in 1995, and are known to be potential problems in generating a variety of bad acts.]

And, for those who forgot the electric car, it was alive and well in the early 1900's, so that no one would have been required to use a horse, even WITHOUT any work on the internal combustion engine. The Wright Brothers might have had a problem with powered flight (they needed an internal combustion engine made of aluminum), but don't forget: they filed their patent application on three-dimensional control of flight BEFORE Dec. 17, 1903. While the folks at the National Academy of Sciences [NAS] working on patent reform haven't figured that out, it is worthwhile to know that Wrights' invention was NOT about powered flight. The Wrights considered "powering" a trivial add-on to what they had invented.

The agreement between Microsoft and Novell announced last November aims to make Novell's SUSE Linux the preferred Linux distribution for Windows networks, and includes technology interchange, joint marketing, and a US$240 million payment to Novell from Microsoft. It also gives Novell customers preferential access to Microsoft's patented technology, which critics warn threatens the integrity of the General Public License (GPL) that governs Linux distribution.

Noting the Novell asserted the agreement was customer-driven, Jedras said: The theme was continued when Novell executive vice-president and chief technology officer Jeff Jaffe shared the stage with Craig Mundie, chief research and strategy officer for Microsoft, for a "fireside chat" to discuss the relationship.

The patent aspect of the agreement was likened to a protection racket. Jedras wrote:

He [Bruce Perens] doesn't have an issue with the technical interoperability, but Perens said the patent portion of the partnership is tantamount to a "protection racket" that breaks moral faith with the spirit of the GPL.

"Here's Novell coming along saying 'We're going to sell you the right to use Bruce's software, which Bruce can't sell himself' – and if you don't get it from them, Microsoft will sue you," said Perens. "It just doesn't sound fair. If this kind of deal continues, people won't want to write this kind of software."

Jedras also said: In a statement, the executive director of the Free Software Foundation, Richard Stallman, said Microsoft patents are being used to give an unfair advantage to Novell, and added such deals "make a mockery" of open source.

**One notes that issues in patent reform are a continuum. So-called patent trolls are on one side of Microsoft, but open-source folks are on the other side. To them, Microsoft might look like a troll, or something like a troll in the Novell-Microsoft deal. It's always "my patents and use thereof are good but those of my competitor are not."

HP alleges that Acer, its Taiwanese competitor, knowingly violated HP patents, which are directed to optical drives, clock frequency switching and power consumption. HP is seeking a jury trial and compensation for the use of its technology in Acer PC products, as well as treble damages for willful infringement of the patents and the payment of all its legal fees.

ComputerWorld says: The lawsuit may be an attempt to slow Acer's breakneck growth and its expansion in the US, according to Henry King, an analyst for Goldman Sachs (Asia) in Taipei. King also said that Acer was probably protected in the patent dispute by cross-licenses held by the companies that contract manufacture PC products on its behalf. Most major PC companies, including HP, Acer and Dell, farm out production to the same contract manufacturers in Taiwan and China, and the contract manufacturers try to sort out patent issues through cross-licenses.

The WashingtonPost quoted King in the following way: "Acer has become a threat that leading PC vendors cannot afford to neglect," he said in a research note. "We understand why competitors would desire a halt to Acer's expansion in the U.S. market." The Post also noted: HP may have taken the step to counter Acer's growing threat on the global stage, with the lawsuit aimed at slowing down its momentum in North America, which now takes up 20 percent of its sales, said JP Morgan analyst Alvin Kwock. "This is a sign that they are recognizing Acer's threat, but it should not affect Acer's financials," said Kwock.

The V-chip, invented by Tri-Vision chairman Tim Collings, is the only solution to the parental controls mandated by the U.S. Federal Communications Commission, Wi-LAN chief executive Jim Skippen told an investor conference call.

The FCC is requiring that content-screening technology be included in all televisions, video recorders and other broadcast reception devices sold in the United States. But so far Tri-Vision has signed up just 42 U.S. licensees — 30 per cent of the potential market — each paying about $1 per device.

Others, including giants like Sony and Samsung, are brushing off Tri-Vision because its small size makes it difficult to enforce its patent rights, Skippen said.

"It would be very hard for them to justify paying $100 million to a company with a market cap of less than that and with only $6 million in the bank, given how expensive U.S. litigation is," he said.

Kappos says: "We publish patent applications, but then limit feedback that can be provided to the USPTO by experts from the public." Rule 1.99 allows third parties to send in prior art during the patent examination. The "limit" is a time limit (two months), not a limit on the ability to give feedback.

Kappos says: "For example, patent award damages are often ratcheted up if the courts find the infringer to have intentionally ignored existing patent protections. So the system actually rewards those who haven't checked to see whether a patent already exists." Think about what Kappos said in those two sentences.

Kappos follows with: "Rules that lead companies to place blinders on their developers is a startling sign that patent law has lost touch with the concept of teaching the public about new inventions, which is, after all, the reason for granting patents." Kappos does not mention that patent infringement itself is strict liability. If you infringe, you will lose the case whether or not you knew about the patent.

Kappos writes: "the U.S. gives precedence to those who are first to invent, but not necessarily the first to file a patent application. That opens the door to disputes between a patent holder and a party that can argue it came up with the idea first—even if it hasn't yet applied for a patent." IPBiz notes there are no patent interferences involving a party who has not applied for a patent.

Kappos mentions IBM's role in peer-to-patent: "While the USPTO is dependent on Congress to establish the patent laws, it has already started making internal improvements. This spring it is experimenting with a program that will enable expert volunteers, including those from IBM, to provide feedback to patent examiners on selected patent applications. Better and more efficient patent examination will improve patent quality by reducing the issuance of overbroad patents." [IPBiz notes some of the patent applications are from IBM.]

Kappos continues: "By bringing 21st-century knowhow to a 200-year-old institution, the USPTO is performing a classic arbitrage: pairing those who have expertise, motivation, and access to information with those who need it but lack the resources to generate it." Kappos does not mention that this will allow competitors to review unfavorably patent applications they might deem threatening.

Of business method patents, Kappos does not swear them off: "For example, when IBM, the top holder of U.S. patents, seeks patents for business methods, it aims to do so only for those methods underpinned by deep technical content. Pure business methods can be difficult to examine and tempt some to seek patents of questionable merit."

The "patent troll" issue morphs into "patent pawn shops."

Kappos suggests that there are many patents of low technical quality:

"IBM also is encouraging other patent practitioners to follow its lead with a sort of voluntary, corporate Hippocratic Oath that would institutionalize innovation-friendly patenting behavior. For instance, if more companies focused on ideas of higher technical quality, were transparent about which patents they owned or were applying for, helped review public patent filings, and permitted others to comment on their own pending patents, the likelihood of legal controversy would be reduced."

***IPBiz notes

Separately, of the "review by third parties" aspect, some people might find it interesting to review the purported relevance of the paper "Development of Advanced Hitachi Electronic Patent Application System Toward a New Patent Age of Improved Support for the Operation of an Intellectual Property Department" (Yukihiko Takada and Kiyonobu Matsumoto, 74 JPTOS 315 (1992)) to the claims of the patent discussed by Jaffe and Lerner in Innovation and Its Discontents. There are a lot of things that might appear to be relevant to patent examination that are not relevant at all.

Specifically, let's go to text in Innovation and Its Discontents:

At page 144:

Consider Patent No. 6,049,811, which is for a “Machine for Drafting a Patent Application and Process for Doing So.” Describes a computer that poses a series of questions to a potential patentee, asking him to describe his invention. The application for this patent cited as relevant prior art just one other patent and two published articles.

Greg Aharonian pointed out, a line of research at Hitachi anticipated this event by many years (165)

In 1992 JPTOS published an article by two of the managers of Hitachi ’s Intellectual Property Division, describing in detail their development of a new system to automate the patent application process (166). Apparently the examiner also missed this publication in his search of prior art. [74 JPTOS 315-334 (1992)]

The book Innovation and Its Discontents has been reviewed by a number of intellectual property law professors. None have commented on this example, which in fact is central to the allegation that the USPTO is missing key references in examining patents.

The first claim of US 6,049,811 states:

A machine for drafting a patent application having at least sections including claims, a summary of the invention, an abstract of the disclosure, and a detailed description of a preferred embodiment of the invention, said machine comprising:

one or more input devices, one or more output devices, and a computer with memory for receiving and storing data from the input devices, transmitting data to the output devices, and storing program steps for program control and manipulating data in memory;

the computer, through input and output devices, requests and stores primary elements (PE) of the invention that define the invention apart from prior technology before the claims are drafted;

the claims are drafted before the summary of the invention, abstract, and the detailed description of a preferred embodiment of the invention is drafted; and

the computer requires drafting the sections in a predetermined order prohibiting jumping ahead to draft a latter section.

Without commenting on whether this claim is valid, the pertinent question is whether 74 JPTOS 315 anticipates the claim.

One gets a hint that 74 JPTOS 315 is about something entirely different than the '811 patent at page 320: which states "The distributed patent offices convert the application documents and specifications (prepared on word processors) to electronic application format." One also has the text: "Each patent specialist is furnished with a word processor unit for the preparation of patent specifications." If one looks at the figure on page 321, one finds a cartoonish image captioned "inut to computer of inventor's manuscript." Another cartoonish image is captioned "order a prior art search." Another cartoonish image shows "break up of invention" which has pictures of people at a conference table. Another cartoonish image has "evaluation" with one man sitting at a table with papers (no computer).

At page 322, one sees that the JPTOS document does NOT teach the elements of the '811 patent. The JPTOS article states the first step in processing the application is the preparation of a patent application manuscript by the inventor. There is NO teaching of a sequence of "claims before summary of invention," etc. The "advance" disclosed in the JPTOS article is that "the inventor prepares the patent specification manuscript on a word processor." Of course, the inventor has already written down everything (in no particular sequence) on paper, as Figure 5, on page 321 shows. There is NO TEACHING in the JPTOS article of what is in claim 1 of the '811 patent.

The episode on page 144 of Innovation and Its Discontents illustrates a number of things:

#1. Jaffe and Lerner seem to be uninformed about the meaning of prior art. To paraphrase Emerson, the more they talked about the failures to find prior art, the more I wanted to check the prior art they said was unfound.

#2. The statement by Jaffe and Lerner, "Apparently the examiner also missed this publication in his search of prior art," is entirely irrelevant. The examiner was totally correct in not citing a reference that had nothing to do with the claims.

#3. If Jaffe and Lerner, who supposedly know something about patents, as well as all the intellectual property professors who reviewed this book, spent a lot of time on this but missed a rather fundamental mistake, what's going to happen when people of LESS SKILL in patents and LESS TIME to study a matter are unleashed in the peer-to-patent program?

#4. What is one supposed to make of Kappos' statement: "By bringing 21st-century knowhow to a 200-year-old institution, the USPTO is performing a classic arbitrage: pairing those who have expertise, motivation, and access to information with those who need it but lack the resources to generate it." In Innovation and Its Discontents one had the 21st century expertise, motivation and access to information of numerous professors to a rather simple example of the application of prior art to a patent claim, and look at the result.

Tuesday, March 27, 2007

Flashback: conflicts of interest in patent cases

On January 14, 2004, the New York Supreme Court (the trial court in NY) wrote:

In keeping with the policy of prohibiting multiple conflicting representations without the clients' consent, P&E's representation of both plaintiffs and UR on related patent issues, without informing plaintiffs, without obtaining plaintiffs' waiver or consent, constitutes a breach of DR 5-105.

However, this Court has concluded that a violation of DR 5-105 has occurred and by a copy of this order will report its findings to theDisciplinary Committee.

An article published online in Nature on February 13, 2007 by free lance writer Eugenie Samuel Reich included charges by Univerity of Illinois professor Ken Suslick against an investigation of bubble fusion work done at Purdue:

"They apparently narrowly focused the charge and avoided the question of whether the research was doctored," says Ken Suslick, a chemist at the University of Illinois at Urbana-Champaign who has been attempting to replicate Taleyarkhan's claims. Suslick is one of several researchers worried that Taleyarkhan's work may be fraudulent, and he wrote to Purdue about his concerns in June 2006. These include the apparent duplication of data between reports of supposedly independent experiments4 (first raised by Nature), and a report5 that the spectrum of neutrons that Taleyarkhan claims to have detected from bubble fusion exactly matches that of a standard radioactive source called californium. Taleyarkhan has since replied that when he measures neutrons emitted by californium in his lab, he finds something quite unlike what he sees from his fusion experiments6. But a recent preprint points out that Taleyarkhan omitted some of the original spectral data in his reply, and that the full data set still looks like californium7.

IPBiz notes that a subsequent inquiry by Congressman Brad Miller evolves from the failure of Purdue to deal with the charges raised by Suslick in June 2006. Both Suslick and Taleyarkhan receive money from DARPA in this area. Reich wrote:

The university never responded to Suslick's concerns. Peter Dunn, Purdue's associate vice-president for research, told Nature that he believes the university followed its procedures. He declined to comment on why he never replied to Suslick, or on whether evidence related to Suslick's concerns was forwarded to either inquiry. Purdue hasn't revealed the identities of the members of the second inquiry panel, but Dale Compton, a professor of industrial engineering at Purdue and a member of the first panel, says he has no recollection of being asked to consider the questions about Taleyarkhan's data.

IPBiz notes that Reich questioned the procedure of the inquiry at Purdue:

Lefteri Tsoukalas, who asked Purdue to investigate Taleyarkhan in February 2006, has called the announcement "an outrage". Tsoukalas was head of Purdue's nuclear-engineering school until he resigned in October 2006 in protest at the way the university was handling the concerns. He notes that the usual procedure for handling allegations of scientific misconduct is to hold a preliminary inquiry, then either proceed with an investigation or close the matter. That did not happen in this case; instead, the university ran a second preliminary inquiry. Apart from Tsoukalas, calls by Nature have failed to locate anyone who raised concerns about Taleyarkhan's work who was interviewed during either inquiry. "Purdue's finding is as mysterious as bubble fusion itself," says Tsoukalas.

IPBiz notes that Reich brings up Putterman:

Seth Putterman of the University of California, Los Angeles, who has also been trying to replicate bubble fusion, thinks that Taleyarkhan's work is invalid. "Purdue's defence of Taleyarkhan's approach to scientific research taints their reputation," he says. "If Purdue were interested in maintaining their credibility they should have appointed external members to their panel." Mason, who is ultimately responsible for academic affairs at Purdue, did not respond to Nature's requests for comment.

Reich did not mention that Putterman received funding to do the investigation from Britain's BBC and Reich did not mention capital equipment Putterman may have received in the course of this inquiry. Reich DID mention money received (an spent) by Taleyarkhan:

Suslick, Putterman and Taleyarkhan had received funding from the US Department of Defense's Advanced Research Projects Agency (DARPA) for a project to test Taleyarkhan's original claims. Taleyarkhan has spent around US$200,000 of this money on his bubble-fusion experiments. A spokeswoman for DARPA, Jan Walker, told Nature that although Purdue has not formally notified the agency of the inquiry or its results: "We are aware that an inquiry has taken place and are currently reviewing what, if any, action is required on our part."

Monday, March 26, 2007

Relevant to previous posts on IPBiz about CIRM granting money to an entity controlled by K.Y. Cha, Mary Engel of the LA Times wrote on March 26 an article entitled "Stem cell granted OKd for LA center linked to allegations."

The LA Times piece discussed one article authored by Cha which is now the subject of a plagiarism controversy. The LA Times did NOT discuss the associated patent problem, nor problems with a different article by K.Y. Cha in the Journal of Reproductive Medicine.

Leaving aside any issues with K.Y. Cha, the last sentence of the LA Times piece is of relevance to discussion about "cures from embryonic stem cell research." The last sentence says: "The CHA proposal would use a patient with Lou Gehrig's disease as a donor, thus creating a line of stem cells with the disease that could be used to study it and test treatments." In other words, the CHA proposal, if fully implemented, will yield a research tool TO TEST OTHER TREATMENTS. In itself, it is not a treatment and not a cure.

Those in the patent realm remember the case of the University of Rochester v. Searle. Rochester did develop a research tool of relevance to COX-2 inhibitors. It could TEST something to see if it was a COX-2 inhibitor. Rochester got a patent for a method of treatment using COX-2 inhibitors and immediately asserted the patent against a company, Searle, that actually had made a COX-2 inhibitor. Millions of dollars were spent in litigation. Rochester, of course, lost on summary judgment. In a final twist, it was learned that certain COX-2 inhibitors were dangerous to patients, and that this information had been known BEFORE one COX-2 inhibitor (VIOXX) went to market.

One commenter on IPBiz analogized work on embryonic stem cells to work on the internal combustion engine. The issue here is not the ability to do work on embryonic stem cells. The federal government does not bar work on embryonic stem cells. It limits federal grant money for work on embryonic stem cells. The internal combustion engine was developed without government support. In the case of the airplane, the Wrights developed three-dimensional control WITHOUT any government support, while a competitor (who failed miserably) received great assistance. In the present matter with Cha, CIRM should check to see whether those who are to receive state funds have connections to an entity who will profit from the research, whether those connections are past, present, or future.

[A complete post on the LA Times article on March 26, 2007 was completely lost by blogger. Blogger is behaving in an increasingly erratic manner.]

The pilot, led by the Institute for Information Law and Policy at New York Law School and the Patent and Trademark Office, initially will accept 250 patent applications from major high-tech firms. IBM, Intel, Microsoft and others have agreed to be guinea pigs, said Beth Noveck, the professor leading the effort.

This communal approach will let the public submit existing inventions known as "prior art" and comment on their relevance to patent applications, Noveck said at a Capitol Hill briefing. Reviewers will rank submissions so PTO examiners can review the prior art deemed most relevant by the community.

The rollout of the "Peer to Patent Project" coincides with increased congressional attention to patent reform. Recent House and Senate proposals would have created a definitive test for "willful" infringement, and the pilot can further that goal, she said. "This is not a substitute but a compliment [sic] for a reform agenda."

The Washington Post notes: this wiki-type experiment is expected to start around June 1.

***Separately, from the dallasnews:

Dallas mayoral candidate Darrell Jordan says he did not plagiarize when lifting, verbatim or nearly verbatim, entire sections of other people's documents in crafting "The Darrell Jordan Accountability Pledge & Plan of Action to Reduce Crime" and "The Darrell Jordan Crime Reduction Plan."

"If there are similarities, there are similarities. Darrell looks at other ideas where people have been successful," said Jack Klaus , Mr. Jordan's campaign manager. "Just because you like a good idea that's out there doesn't make it plagiarism. If it's a good idea, it's a good idea."

IPBiz notes: "plagiarize with pride," just like the Harvard Business Review tells us.

from 88 JPTOS 1068:

Having a different focus, businessmen a priori are not necessarily friendly to intellectual property. In an article in the Harvard Business Review in April 2004, [FN6] one of the subheadings was "Plagiarize with pride," followed by the text "Softball competitors like to think that their bright ideas are sacred. But hardball players know better. They're willing to steal any good idea they see --as long as it isn't nailed down by a robust patent -- and use it for themselves." Note that the authors referred to a "robust" patent. The authors also stated: "The Hardball Player ventures closer to the boundary, whether established by law or social conventions, than competitors would ever dare." [FN7] Other authors at the Harvard Business Review have suggested that there are a lot of non-robust patents and, in so doing, have given much force to the idea of a patent quality issue.

The active ingredient in Norvasc is amlodipine besylate. Amlodipine is a dihydropyridine, a heterocylic molecule with a ring of 5 carbons and one nitrogen. The besylate compound is formed by reaction of the basic amlodipine with benzene sulfonic acid. [Besylate is a synonym for benzene sulfonate. An insult to chemistry occurs in footnote 3 of the opinion, wherein hydrochloride is referred to as an "anion." The CAFC blames Pfizer.]

The CAFC details the prosecution history. Of relevance to patent reform, the patent in question arose as a continuation filed to dispute a final rejection.

At district court, an obviousness rejection had been made over the '909 patent and an article by Berge (which showed besylate anions were used at a frequency of 1 in 400 drugs). The district court found there was no predictable way to determine how an anion would influence drug properties AND that the besylate compound was UNEXPECTEDLY superior. [Footnote 4 of the opinion, dealing with how the district court dealt with Berge, cautions against oral bench rulings in a trial such as this.]

The CAFC criticized a number of aspects of the district court ruling. The district court had ruled there was a prima facie case of obviousness (which favored Apotex) because the examiner had found one DURING prosecution. The self-evident problem with that thinking is that the patent ISSUED. Thus, there is a presumption of validity. The CAFC cited Faulding, 230 F.3d 1320, although they could have cited a textbook.

The patent challenger must present a prima facie case of obviousness, and then the patentee must rebut.

The CAFC made an interesting point which produced Pfizer's demise. The CAFC admitted neither the claims nor the specification of the prior art '909 disclosed the besylate anion, but they didn't exclude it either. Thus, the broad genus claimed in the '909 encompassed the later species claimed in the '303.

Of interest to the coming decision in KSR v. Teleflex, the CAFC noted the district court failed to find "motivation to combine" but deemed this harmless error. Later, in the case, the CAFC cites DyStar, 464 F.3d at 1361. The CAFC got into the matter than Berge disclosed 53 pharmaceutically-acceptable anions. The CAFC emphasized that the anion used (the besylate part of the drug) had no therapeutic effect. The CAFC found there was clear motivation to combine.

The CAFC next moved to "reasonable expectation of success." Yes, the CAFC did cite In re O'Farrell, 853 F.2d 894. Curiously, statements made by Pfizer in the Dr. Reddy's case came back to haunt Pfizer in this case. (359 F.3d at 1366)

The CAFC had a separate section on "obvious to try." The CAFC included text from DyStar, 464 F.3d at 1367. The CAFC likened this case to an "optimization of range" case and cited In re Peterson, 315 F.3d 1325. Finding the besylate anion was deemed nothing more than routine experimentation strategy. The CAFC cited Merck, 874 F2d at 809.

The CAFC held there was a prima facie case of obviousness and moved on to secondary considerations.

Following a successful patent defense on Zyprexa, Lilly now faces challenges to Gemzar (gemcitabine, an injectible chemotherapy that treats several forms of cancer) from Sicor Pharmaceuticals Inc., Mayne Pharma Inc. and Sun Pharmaceutical Industries Inc. through challenges mounted via provisions of the Hatch-Waxman Act. The paragraph IV challengers argue that either the compound or method of use are obvious and can't be protected by a patent.

A spokesperson for Mayne (now owned by Hospira) stated "we will vigorously assert our rights to continue to help reduce the overall costs of health care through the introduction of high quality, less costly generic products." The fraction of drugs used which are generic has risen; generic drugs accounted for 56 percent of all U.S. prescriptions dispensed in 2005, a 211 percent increase over the past two decades, according to Pharmaceutical Research and Manufacturers of America.

A spokesperson for Lilly noted: Patent defenses are crucial because companies spend anywhere from $800 million to $1.2 billion to develop a drug and bring it to market.

IPBiz has noted elsewhere of patent issues in India pertaining to the cancer drug Gleevec (imatinib mesylate). As noted on cancerconsultants : Gleevec is a biological agent that is approved for the treatment of GIST as well as chronic myeloid leukemia (CML). Gleevec has activity in several biological pathways implicated in the development and/or expression of cancer. It tends to bind to targets within a cell and slows or stops the uncontrolled growth of the cancer cells with certain genetic mutations. Because the disease is often stabilized while a patient is being treated with Gleevec, researchers have questioned whether disease stabilization would be maintained if these patients were taken off Gleevec for a period. See also Blay J-Y, Le Cesne A, Ray-Coquard I, et al. Prospective multicentric randomized Phase III study of imatinib in patients with advanced gastrointestinal stromal tumors comparing interruption versus continuation of treatment beyond 1 Year: The French Sarcoma Group. Journal of Clinical Oncology. 2007; 25: 1107-1113.

Sunday, March 25, 2007

ABBA

AP reported: Former ABBA stars Bjorn Ulvaeus and Benny Andersson won a court battle in Sweden's capital March 25, 2007 over who wrote the script to one of their musicals. Their opponent was writer Carl-Johan Seth concerning the rights to the script for the Swedish musical "Kristina fran Duvemala." Ulvaeus and Andersson wrote the songs and music for the play, but threatened to never stage the musical again if they lost the dispute to Seth.

ABC News mentions cardiac treatment using adult stem cells

On Sunday, March 25, 2007, Timothy Johnson reported on ABC Evening News initial research results on the use of adult stem cells to treat cardiac patients. The stem cells were derived from the patient who was treated, so there no immune issues due to a difference between patient and stem cell source. I believe the stem cells were injected into the heart. When asked when this might be available clinically, Johnson responded 3-5 years. I have not yet found a transcript of this report on the ABC website. There is a video available, under the title "Stem Cells Yield Heart Hope. A Study Shows Adult Stem Cells, Not Embryos, Could Help Treat Heart Damage." The URL for the video is http://abcnews.go.com/Video/playerIndex?id=2980424.

StemCellPatents.com congratulates Osiris Therapeutics for promising data reported today [3/25/07] using the PROVACEL(TM), adult mesenchymal stem cell product for treatment of post myocardial infarction patients. The data, which was presented by Joshua Hare M.D. at the American College of Cardiology's Innovation in Intervention: i2 Summit, overviewed six month follow-up of 53-patients treated in a double-blind placebo-controlled manner with intravenous administration of allogeneic stem cells. Reported results included "significantly lower rates of adverse events, such as cardiac arrhythmias, as well as significant improvements in heart, lung and overall condition."

"To our knowledge, this is the first placebo-controlled clinical trial utilizing allogeneic stem cells administered intravenously in cardiac patients," said Dr. Zhoahui Zhong, Chairman of StemCellPatents.com. "The fundamental importance of the data reported today resides in two fundamental differences between this trial and numerous other stem cell cardiology trials. The first being that the cells were administered intravenously, thus implying that direct myocardial injection of stem cells, which is a relatively invasive procedure may not be strictly necessary. The second being that the cells were derived from a standardized off the shelf, allogeneic source, thus the procedure did not require patients to undergo bone marrow aspiration, yet another procedure associated with a certain degree of invasiveness."

***As an aside

The link to the ABC video was part of the initial post, but somehow was not included by blogger, which has been behaving erratically, especially as to the "gotcha" letters. Also, of earlier comments by others about how New Jersey politicians are tricking/duping Jerseyans by using more of the $5 million for research on adult stem cells than on embryonic stem cells, the ABC report is evidence that ACTUAL treatments for people are more apt to come from adult stem cell work BEFORE they come from embryonic stem cell work. Those people who are concerned about TREATMENTS, as distinct from useful diagnostic methods (eg, in genetic screening), should heed this well.

Rush principal investigator cardiologist Dr. Gary Schaer, head of the Rush Cardiac Catheterization Laboratory, says one reason the study results are so promising is that these stem cells can be used without tissue typing and do not trigger an immune response, and are available for every patient.

The mesenchymal stem cells (MSC) are found in the adult bone marrow and have the potential to develop into mature heart cells and new blood vessels. The MSC cells are derived from normal, healthy adult volunteer bone marrow donors and are not derived from a fetus, embryo or animal. Because they are in an early stage of development, it is believed that they do not trigger an immune response when placed in someone else's body.

Schaer says the cells were grown in culture to very high numbers, allowing a single donor's cells to treat thousands of patients. "The cells have the ability to expand, or multiply, under controlled conditions, and the expanded cells have the ability to develop into different types of cells in the appropriate environment. One donation can produce billions of MSCs. The cells can be stored for years in a frozen state, ready to be used when they are needed."

How much secrecy is needed in government funded research?

Both the current "bubble fusion" controversy AND the grant procedure at California's CIRM are raising questions about "how much" secrecy is appropriate for government funded work. One writer to IPBiz noted:

My interest in this matter is not so much the cold fusion debate as the secrecy with which Purdue conducted its misconduct investigation and the apparent, per parties involved (or not involved but who should have been involved), deviation from typical misconduct investigation protocol. These are laid out in excruciating detail at most Universities, so such detours should not be difficult to identify. If the problem were as trivial as a technicality related to not acknowledging a sponsor in a publication, I think Purdue would not have diffculty releasing this finding, which would benefit the institution and Dr. Taleyarkhan's ability to continue contributing to the scientific community.

IPBiz notes that the problem at Purdue may be the perceptions, by administrators, of required confidentiality for this type of investigation.

To switch to a different case, that of Eric Poehlman, the investigations into misconduct by Poehlman in Vermont were so "low profile" that Poehlman was able to get a job at the University of Montreal without Montreal knowing anything about the Vermont investigations. See, for example,

As a separate matter, there are many individuals who avoid discussion of scientific misconduct. This author (LBE) served on the Ethics Task Force of the American Chemical Society at the time when the fraud of Jan-Hendrik Schon was being discovered. Although Schon was a physicist (not a chemist), he had chemists as co-authors, which reality presented a great opportunity for the ACS to lay out a policy on co-author responsibility. The other members of the Task Force would not touch this topic. Ironically, the APS grasped the opportunity and did lay out standards on co-author responsibility. Along the same lines, when this author was interviewed by NHK-TV about the Schon matter, this author learned that many institutions would not comment on the Schon matter, long after the facts of the matter were firmly established. The NHK show on Schon has never been broadcast in the United States.

***Separately, a different blog (Medical Writing, Editing & Grantsmanship) had a nice reference to IPBiz:

Update: Dr. Lawrence Ebert (PhD, JD) has expanded this discussion on his own blog, IPBiz. You can also read about Eric Poehlman, who is doing jail time for his scientific misconduct, and the laxity that led to his hiring by the University of Montreal & funding by the Canadian government to the tune of $1.2M. Incredibly, U Montr was shocked - shocked - that Poehlman neglected to mention his ongoing fraud investigations when they recruited him. Fortunately, it seems his research was on the level due north.

In the context of a post on californiastemcellreport relating to the Cha/CIRM matter, I wrote:

I have been interested by the disregard of priority by certain historians. A recent book on the prison at Andersonville published by the University of Tennessee Press contained significant material plagiarized from an earlier book. The "theft" was discovered only when the earlier author was given the later book to review. A different book, on Custer at Gettysburg published by Putnam, portrayed as "novel" a theory that had been published many times before.

Subsequently, I came across another review of the Gettysburg book (Lost Triumph: Lee's Real Plan at Gettysburg—And Why It Failed by Tom Carhart (2005)) which included the following:

One would naturally assume that to date, everything that could or should have been published about the Battle of Gettysburg and its aftermath has already been written. Just in recent years, however, such works as Mark H. Dunkelman, Gettysburg's Unknown Soldier: The Life, Death, and Celebrity of Amos Humiston (1999); Thomas A. Desjardin, These Honored Dead: How the Story of Gettysburg Shaped American Memory (2003); James M. Paradis, African Americans and the Gettysburg Campaign (2005); Margaret S. Creighton, The Colors of Courage: Gettysburg's Hidden History (2004); Earl J. Hess, Pickett's Charge: The Last Attack at Gettysburg (2001); and Carol Reardon, Pickett's Charge in History and Memory (1997) have revealed that the subject of the Civil War's most famous battle is by no means exhausted. Tom Carhart's and Kent Masterson Brown's seminal volumes also aptly demonstrate that the subject of Gettysburg is still a vital and volatile topic, with enough material for both the student of the Civil War and academician alike to relish and interpret. 1 Since the Civil War, a multitude of theories have been promulgated to explain the defeat of Lee's Army of Northern Virginia at Gettysburg, from the failure of Pickett and Pettigrew's Charge to fuse problems or faulty shells used by the Southern artillery. Years after the close of the war, former Confederate, General Harry Heth, passed judgment by stating that "the failure to crush the Federal Army in Pennsylvania ... can be best expressed in five words—the absence of the Cavalry" (as quoted and italicized by John S. Mosby, Stuart's Cavalry in the Gettysburg Campaign [1908], 154). 2 Through the use of primary sources and deduction from the evidence, Carhart reveals the astute knowledge General Robert E. Lee had of the tactics and strategies of Napoleon and demonstrates that the Confederate commander did not simply make a poor tactical decision that fateful day on July 3, 1863, but that "Pickett's Charge ... was at least in part, a massive distraction" (p. 4) of a master plan known only to Lee and possibly a few other key individuals.

The problem with the review by Rolph is simple. It ignores previous work. For one thing, it ignores previously published books which advanced the same thesis. For another thing, it ignores people who wrote about the previously published books. For example, one notes the following from a review by Steven Leonard of a 2002 book by Paul D. Walker:

In The Cavalry Battle that Saved the Union: Custer vs. Stuart at Gettysburg, Paul D. Walker reveals the apparent genius behind the plan: Confederate General Robert E. Lee's grand scheme was to attack with infantry from the front while Confederate General J.E.B. Stuart's cavalry swept into the rear of the Union formations.

Our final book this month is yet another revelation of Robert E. Lee’s real plan at Gettysburg. Tom Carhart, in Lost Triumph: Lee’s Real Plan at Gettysburg—and Why it Failed (G.P. Putnam’s Sons, New York, 2005), contends that Lee planned to attack the Union rear with Jeb Stuart’s cavalry while James Longstreet’s assault struck their front on Cemetery Ridge, and that the plan failed due to the bravery and impetuousness of George Custer. Carhart is not the first to advance this notion of Lee’s plan for July 3. It has been around for many years, but lacks evidence to support it.

In addition to the IPBiz post, I had published my comments in Intellectual Property Today and I had expanded upon them in JPTOS. I am not the only one who has commented on the Carhart book.

But an improper claim of priority remains.

To return to a theme of examination of patent applications, the examiners at the USPTO are charged with finding all pertinent references. If they fail to find something on the level of obscurity of the book by Paul D. Walker, it is a big deal. The examiner who missed such a reference will be criticized. Apparently, when historians fail to find (and/or acknowledge) a book such as that of Paul D. Walker, it is no big deal. Re-inventing the wheel seems to be all right in the history business, but it simply won't do in the patent business. People who are quick to criticize patent examiners should note what a lousy job of identifying prior art is done in other fields, such as history.

A fascinating narrative, and a bold new thesis in the study of the Civil War, that suggests Robert E. Lee had a heretofore undiscovered strategy at Gettysburg that, if successful, could have crushed the Union forces and changed the outcome of the war.

note relevant text in 88 JPTOS 1068. Pertinent to a claim by Senator Webb of Virginia that Nathan Bedford Forrest was never beaten by a West Point educated commander, see footnote 28 of 88 JPTOS 1068:

See also footnote 16 of Robert A. Frezza, A Pocket History of the Personnel Claims Act, 1989 Army Law. 43 (1989) ["In 1863 Colonel John T. Wilder, an Indiana industrialist commanding a brigade in Rosecrans' Union Army of the Cumberland, entered into a interesting contract with his men to buy them Spencer rifles, the best breech-loading infantry weapon available ..."]; note also James H. Wilson's cavalry raid of March 1865 employing Spencer rifles in which a successful charge was made against forces of legendary Confederate commander Nathan Bedford Forrest, even though Union forces were outnumbered 6 to 1. See http://www.bufordsboys.com/UnionCavalrymanVI.htm.

James H. Wilson graduated from West Point. The fact that Wilson defeated Forrest at Selma, which contradicts Webb's assertion, is hardly a secret; from Wikipedia: In 1865, Forrest attempted, without success, to defend the state of Alabama against the destructive Wilson's Raid. His opponent, Brig. Gen. James H. Wilson, was one of the few Union generals ever to defeat Forrest in battle. The point here is not to diminish Forrest's military skills. It should be self-evident that cavalry troops armed with repeating weapons (here Spencer carbines) will have a tremendous advantage over troops with single shot weapons. Custer proved this at Gettysburg on July 3, 1863 against troops of J.E.B. Stuart, and, unfortunately for Custer, re-proved this on June 25, 1876, where he played the role of the technologically-deficient party. [see 88 JPTOS 1068, 1073]

One notes that, at the beginning of the Centennial period (circa 1960), a major US magazine ran a feature describing what might have happened if the South had won. In both the 1960 and 1992 stories, the South and North become separate countries.

[If you are wondering, MacKinlay Kantor's Civil War Centennial piece for LOOK, "If the South Had Won the Civil War" originally appeared in the November 22, 1960 issue of LOOK, producing a deluge of correspondence from readers, leading to a related book in 1961."]

Their findings are published today [3/25/07] in an early online edition of the Proceedings of the National Academy of Sciences.

This discovery takes scientists another step closer to being able to grow embryonic stem cells without the “feeder layer” of mouse fibroblast cells that is essential for maintaining the potency of embryonic stem cells, said Michael Kahn, the study’s primary investigator who recently was named the first Provost’s Professor of Medicine and Pharmacy at USC.

Such a layer is needed because it is currently the only proven method to provide the stem cells with the necessary chemical signals that prompt them to stay undifferentiated and to continue dividing over and over.

Still, growing human embryonic stem cells on a layer of mouse fibroblasts has never made much sense to the scientists forced to do just that.

“Stem cells that grow on feeders are contaminated with mouse glycoproteins markers,” Kahn said. “If you use them in humans, you’d potentially have a horrible immune response.”

And so, in order to take any eventual stem cell-based treatments from the laboratory to the clinic, there needs to be a way to keep the cells growing and dividing without the use of mouse fibroblasts. The discovery of IQ-1, Kahn said, is a significant step in that direction.

**Separately, of a comment on the "timetable" post in IPBiz:

Whether you are for or against research using hesc is not the issue, what is may be that the people of New Jersey expected one thing and got another.

IPBiz notes: unlike the voters in California, who voted on Proposition 71, the voters in New Jersey have not voted on a stem cell bond proposal. Thus, not clear what the expectations are, or were. The current funding of $5 million discussed by the poster Faye was not voted upon by Jersey taxpayers, so there can be no statement of what the expectations of the taxpayers were.

It is clear that many California taxpayers expected patent royalties to flow, and they are going to get hosed.

About Me

I'm a patent lawyer located in central New Jersey. I have a J.D. from the University of Chicago and a Ph.D. from Stanford University, where I studied graphite intercalation compounds at the Center for Materials Research. I worked at Exxon Corporate Research in areas ranging from engine deposits through coal and petroleum to fullerenes. An article that I wrote in The Trademark Reporter, 1994, 84, 379-407 on color trademarks was cited by Supreme Court in Qualitex v. Jacobson, 514 US 159 (1995) and the methodology was adopted
in the Capri case in N.D. Ill. An article that I wrote on DNA profiling was cited by the Colorado Supreme Court (Shreck case) and a Florida appellate court (Brim case). I was interviewed by NHK-TV about the Jan-Hendrik Schon affair. I am developing ipABC, an entity that combines rigorous IP analytics with study of business models, to optimize utilization of intellectual property. I can be reached at C8AsF5 at yahoo.com.